Using MonitorMe for a clinical validation study in a small COPD patient cohort

PROJECT TITLE USING MONITORME FOR A CLINICAL VALIDATION STUDY IN A SMALL COPD PATIENT COHORT
Funding body Med Tech Trials Innovation Support Grant  (MTT-ISG), Medilink East Midlands, East Midlands Academic Health Science Network
Total funding  £50,000
Team
  • Julian Holmes, CEO, Sanandco
  • Jaspal Kaur-Griffin, Sanandco
  • Dr Arwel Jones, Lincoln Institute for Health, University of Lincoln
  • Dr Karen Cox, University of Lincoln
  • Despina Laparidou, CaHRU, University of Lincoln
  • Dr Zahid Asghar, CaHRU, University of Lincoln
  • Prof Niro Siriwardena, CaHRU, University of Lincoln
Team/consortium
  • University of Lincoln
  • Sanandco
Overarching aim

The overarching aim is to validate the MonitorMe device in clinical practice.

MonitorMe is a telephone and Class IIA medical device supplied for the non-critical monitoring of vital signs in the domestic environment. These include peripheral capillary oxygen saturation (SpO2), pulse rate, pulse transit time, temperature and blood pressure (via a commercially available CE marked cuff).  An automated call captures the data together with responses to a health questionnaire and directs the data to the patient’s electronic record. Remote trend analysis by care professionals will identify any patients in need of an intervention.

The objective of MonitorMe is to improve the efficiency of care professionals by helping them to identify those patients with the greatest need of a health intervention, and at the same time to dramatically improve patient’s health outcomes.

Objectives The objectives of this study are to confirm:

  1. The cohort is comfortable operating MonitorMe and they remain confident in using the device throughout the trial.
  2. The associated health questionnaire is easy to understand, simple to provide responses to and appropriate for their needs.
  3. Data can be collected at regular intervals.
  4. Data are accurate compared with vital signs collected through normal home visits.
  5. Data can be repeatedly retrieved by care professionals.
  6. The output of data is easy to interpret by care professionals and is in an appropriate form.
Methods Mixed methods clinical validation study
Outcomes The key outcome is to validate MonitorMe in terms of data accuracy, feasibility and patient acceptability.
Outputs Peer reviewed publications and conference presentations.
Impact If MonitorMe is shown to be effective patients will benefit from being able to go home earlier and convalesce in familiar surroundings following discharge; this might lead to quicker recovery times for patients and the empowerment of both patients and their loved ones of knowing their vital signs are being monitored whilst they recover at home.

 

 

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